Molecularly Tailored Therapy in Advanced Pancreatic Cancer

NCT07802418 | Not Yet Recruiting Phase 2

• 1 other identifier: PA25
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 4

Brief Summary

Pancreatic cancer that has spread or cannot be removed by surgery is difficult to treat. Standard chemotherapy can slow the disease, but the cancer often starts growing again. Some pancreatic cancers have specific genetic changes that may be targeted by medicines already available in Denmark. It is not yet known whether selecting treatment based on these genetic changes is more effective than standard treatment. TAILOR-PANC is a randomized phase 2 study evaluating treatment guided by the molecular characteristics of the cancer. Adults with advanced pancreatic cancer whose disease has progressed during or after first-line chemotherapy may participate if molecular testing results are available. A national molecular tumor board will review these results and determine whether the cancer has a genetic change that can be matched to an available targeted treatment. Participants with a suitable genetic change will be randomly assigned in a 1:1 ratio to receive either the matched treatment recommended by the molecular tumor board or standard second-line treatment according to Danish guidelines. Participants without a suitable genetic change will receive standard treatment and will be followed in a separate observational group. Treatment will continue until the cancer progresses, unacceptable side effects occur, the participant withdraws consent, or the treating physician decides that treatment should stop. The main purpose of the study is to determine whether molecularly matched treatment delays cancer progression compared with standard treatment. The study will also evaluate overall survival, tumor response, side effects, and quality of life. Participants in the randomized groups will undergo scans, blood tests, and quality-of-life assessments at baseline and approximately every 8 weeks. Optional blood and tumor samples may also be collected through the BIOPAC project to explore biomarkers that could help predict treatment response or side effects.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Advanced pancreatic cancer; Metastatic pancreatic cancer; Locally advanced pancreatic cancer; Precision oncology; Precision medicine; Molecularly tailored therapy; Molecularly matched therapy; Targeted therapy; Molecular profiling; Genomic profiling; Whole-genome sequencing; Next-generation sequencing; Actionable molecular alterations; Molecular tumor board; Second-line treatment; Treatment selection; TAILOR-PANC; DPCG-02

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival in Randomized Participants

  Progression-free survival is defined as the time from the first dose of study treatment to investigator-assessed objective disease progression according to RECIST version 1.1 or death from any cause in the absence of documented progression, whichever occurs first. Participants without progression or death at the analysis will be censored at their latest evaluable RECIST assessment. The primary comparison is between molecularly tailored therapy (Arm 1) and standard-of-care therapy (Arm 2).

  1 year

Secondary Outcomes (9)

• Overall Survival in Randomized Participants

  1 year

• Overall Survival Rate at 6 Months

  6 months

• Overall Survival Rate at 12 Months

  12 months

• Confirmed Objective Response Rate

  1 year

• Disease Control Rate at 4, 6, and 12 Months

  12 months

Other Outcomes (3)

• Overall Survival Across Molecular and Treatment Cohorts

  1 year

• Objective Response Rate Across Molecular and Treatment Cohorts

  1 year

• Correlations of Tumor and Blood Biomarkers With Clinical Outcomes

  Up to 5 years

Study Arms (3)

Arm 1: Molecularly Tailored Therapy

EXPERIMENTAL

Participants with an actionable, reimbursed molecular alteration will receive molecularly tailored treatment selected on a case-by-case basis following review by the national molecular tumor board. The treatment will be matched to the identified alteration and may differ between participants. Treatment will be administered according to the relevant drug-specific requirements and continued until disease progression, unacceptable toxicity, withdrawal of consent, or clinical deterioration based on the investigator's judgment.

Drug: Arm 1: Molecularly Tailored Therapy

Arm 2: Standard-of-Care Therapy

ACTIVE COMPARATOR

Participants with an actionable, reimbursed molecular alteration who are randomized to this arm will receive standard second-line systemic therapy according to current Danish clinical guidelines. The specific treatment will be selected by the treating investigator based on previous therapy, clinical condition, and applicable guidelines. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or clinical deterioration based on the investigator's judgment.

Drug: Arms 2: Standard-of-Care Therapy

Arm 3: Standard-of-Care Observational Cohort

OTHER

Participants without an actionable, reimbursed molecular alteration will not undergo randomization. They will receive standard-of-care therapy according to current Danish clinical guidelines and will be followed as a non-randomized observational cohort. Treatment selection, assessments, and follow-up will be performed as part of routine clinical care. Data from this cohort will support exploratory comparisons with participants whose cancers contain actionable molecular alterations.

Drug: Arm 3: Standard-of-Care Observational Cohort

Interventions

Arm 1: Molecularly Tailored Therapy DRUG

Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib

Arm 1: Molecularly Tailored Therapy

Arms 2: Standard-of-Care Therapy DRUG

Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine

Arm 2: Standard-of-Care Therapy

Arm 3: Standard-of-Care Observational Cohort DRUG

Gemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine

Arm 3: Standard-of-Care Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18 and over)
• PC confirmed by cytology or histology
• Written informed consent before any specific study procedures
• Available personalized report communicating the molecular testing results and detailed treatment options
• Participants must have received and progressed during or after 1 line of systemic chemotherapy in the advanced setting (gemcitabine or 5-FU based regimens) or within one year of the adjuvant/neoadjuvant treatment
• Notes:
• In general, discontinuation of 1 drug in a multi-drug regimen and continuation of other drug(s), is considered part of the same line of treatment. Restarting the same regimen after a drug holiday or maintenance chemotherapy can also be considered part of the same line of treatment
• Switching from IV (5-FU) to an oral formulation (capecitabine) of the same drug is also considered part of the same line of treatment
• Minimum time from first systemic therapy for advanced PC to progression should be at least 2 months
• ECOG Performance Status (PS) 0-2
• Participants must have normal organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
• Platelet count ≥ 75 x 10⁹/L
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST/ALT ≤ 5 x ULN

You may not qualify if:

• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
• Allergies and Adverse Drug Reaction
• History of allergy to study drug components
• History of severe hypersensitivity reaction to any monoclonal antibody (applicable for participants to receive a monoclonal antibody in the trial)
• WOCBP who are pregnant or breastfeeding

Sponsors & Collaborators

• Herlev Hospital: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (4)

Department of Oncology

Aalborg, 9000, Denmark

Location

Department of Oncology

Aarhus, 8200, Denmark

Location

Department of Oncology

Herlev, 2730, Denmark

Location

Department of Oncology

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Inna Markovna Chen, MD

  Herlev Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inna Markovna Chen, MD

CONTACT

+45 38682898; Inna.Chen@regionh.dk

Kevin Zi Ming Lim, MD

CONTACT

+45 38689134; kevin.zi.ming.lim@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 3, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)